A Phase I/II, Randomized, Double-blind, Placebo-controlled, Single-center Study of the Effects of Cannabidiol (CBD) on Opioid Plasma Levels in Participants With Chronic Radiculopathic Pain Syndromes Maintained on Chronic Opioid Therapy (COT)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- Change in Opioid Analgesic Plasma Levels
研究概览
简要总结
This double-blind, placebo-controlled, exploratory trial is designed to compare effects of oral CBD 600mg to placebo (PCB) in 20 outpatients with chronic spinal radiculopathies (without co-occurring Opioid Use Disorder), maintained on stable opioid analgesics for a minimum of 1 month. The trial duration will be approximately 2 weeks (from the point of randomization) of daily CBD 600mg vs placebo. Safety and tolerability of CBD will be assessed throughout the trial. The secondary efficacy outcome is change in pain outcomes from baseline to end of the treatment period at 2-weeks post-randomization/initiation of treatment with a Mixed Model for Repeated Measures (MMRM) statistical analysis performed to assess between group treatment effects of CBD relative to placebo.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
盲法说明
The trial will employ a double-blind pharmacologic intervention methodology where the investigational drug (CBD) and matched placebo oral pills will be masked in identically appearing capsules provided by the drug sponsor.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males and females aged ≥18
- •Diagnosis of radicular CNCP (i.e. lumbar, cervical, thoracic)
- •Maintained on stable dose opioid therapy for a minimum of 1 month
- •o Note: Morphine Equivalent Daily Dose (MEDD) will be calculated using 2 reference documents: Guideline and conversion table to calculate MEDD from Centers for Medicaid and Medicare Services (CMS); Guidelines from the Centers for Disease Control and Prevention (CDC) intended for calculating total daily dose of opioids for safer dosage of opioid pharmacotherapy
- •Able to provide voluntary informed consent
- •If a woman of childbearing potential or a man, are willing to use approved form of contraception from screening for duration of the trial
排除标准
- •Exclusionary medical conditions (e.g., unstable cardiac, hepatic, renal, neurologic illness) or any medical illness that in the opinion of the study physician poses a potential medical danger to the participant
- •Exclusionary laboratory abnormalities (clinically significant abnormalities of complete blood count or chemistries, significantly impaired liver function)
- •Current substance use disorder (including Opioid Use Disorder) other than nicotine or caffeine
- •At screening, a positive urine toxicology test for: amphetamines (AMP), barbiturates (BAR), buprenorphine (BUP), benzodiazepines (BZO), cocaine (COC), 3,4-methylenedioxymethamphetamine (MDMA), methamphetamine (MET), methadone (MTD), phencyclidine (PCP), and tetrahydrocannabinol (THC)
- •At screening, an alcohol level greater than 0 on a breathalyzer
- •Severe psychiatric conditions including past or current DSM5 diagnosis of schizophrenia, schizoaffective disorder, bipolar disorder
- •Current significant suicidality (assessed using the C-SSRS), any suicidal behavior in the past 12 months, or any history of suicide attempts
- •Current use of recreational or medical cannabis or any product containing CBD
- •Pregnancy or lactation
- •Current use of concomitant medications metabolized primarily by CYP2C19 isoenzymes
- •Current use of concomitant medications significantly or primarily metabolized by CYP3A4 with the potential for adverse drug-drug interactions with CBD (i.e., ketoconazole, rifampicin)
- •Current use of concomitant medications with a narrow therapeutic window significantly or primarily metabolized by CYP2C9 with the potential for adverse drug-drug interactions with CBD (i.e., warfarin)
- •Current use of concomitant medications known to have adverse drug-drug interactions with CBD (i.e., valproate) or the potential to cause significant drug-drug interactions (i.e., clobazam).
- •Known allergy to CBD or any ingredient of the study compound
- •Currently enrolled in a clinical trial assessing the effects of an anti-pain intervention
研究组 & 干预措施
Cannabidiol (CBD)
干预措施: Cannabidiol (Drug)
Placebo (PCB)
干预措施: Placebo (Drug)
结局指标
主要结局
Change in Opioid Analgesic Plasma Levels
时间窗: Baseline, Week 2 Post-Initiation of Treatment
Opioid (i.e. the particular opioid used by a participant) analgesic plasma levels will be determined via High Performance Liquid Chromatography/Tandem Mass Spectrometry (LC-MS/MS).
Change in CBD Plasma Levels
时间窗: Day 1 Post-Initiation of Treatment, Week 2 Post-Initiation of Treatment
CBD plasma levels will be determined via High Performance Liquid Chromatography/Tandem Mass Spectrometry (LC-MS/MS).
次要结局
- Change in Score on Pain Catastrophizing Scale (PCS)(Baseline, Week 2 Post-Initiation of Treatment)
- Change in Brief Pain Inventory (BPI) Score(Baseline, Week 2 Post-Initiation of Treatment)